Germany-based biotechnology company Evotec has reported the results of a Phase II proof-of-concept study investigating the potential of EVT 302, a reversible and selective inhibitor of monoamine oxidase B as an aid to smoking cessation. The study study failed to demonstrate any convincing support for the use of EVT 302 as an aid to smoking cessation.
According to Evotec, EVT 302 failed to demonstrate any significant improvement in the quit rate compared with placebo. The combination of EVT 302 with a nicotine replacement patch also failed to demonstrate any significant benefit over nicotine replacement therapy (NRT) alone.
The study was well performed and the placebo quit rate was well within expectations ensuring adequate power to demonstrate any treatment effect. Throughout this study EVT 302 was well tolerated with subjects experiencing very few treatment-related adverse events, the company said.
The study reported was performed double blind in Germany with 414 otherwise healthy smokers who were motivated to quit smoking. The study assessed whether eight weeks treatment with EVT 302 resulted in an increase in quit rate compared to placebo. The study also included a comparison of EVT 302 added to NRT (21mg patch once daily) versus NRT alone to see if there was any additive benefit for the two treatments taken together.
Tim Tasker, executive vice president of clinical development at Evotec, said: Once a full analysis of all the data is completed Evotec will re-assess the future of EVT 302, given the overall potential of monoamine oxidase B-inhibitors in a number of indications and the excellent safety profile demonstrated by EVT 302 in this study.